510(k) submissions to FDA declining


emergo-1x1By Stewart Eisenhart, Emergo Group

The number of US-based medical device manufacturers submitting 510(k) premarket notification applications to the Food and Drug Administration has decreased over the past four years, according to a new Emergo study, while applications from European and Asian firms have increased.

Get the full story here at the Emergo Group’s blog.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MedicalDesignandOutsourcing.com or its employees.

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